a single oral dose study of asp015k in healthy volunteers assessing the relative bioavailability across three tablet strengths from a new formulation of asp015k

Conditions: Bioavailability of ASP015K; Pharmacokinetics of ASP015K; Healthy Subjects

Summary: the purpose of this study is to determine the relative bioavailability and pharmacokinetic profiles from three strengths of a new tablet formulation of asp015k and to evaluate the safety and tolerability after a single dose of three different strengths of a new tablet formulation.

eligible subjects will be admitted on day-1 and remain confined on the unit for 16 days. each subject will receive a single dose of study drug per the defined treatment periods on the mornings of day 1, day 6 and day11. there will be a minimum of 5 days between each consecutive dose group. any subject discontinuing the study prior to completion should have all end of study evaluations completed.

Eligibility criteria:
inclusion criteria: * subject weighs at least 45 kg and has a body mass index (bmi) of 18-32 kg/m2 * male subject agrees to sexual abstinence, is surgically sterile or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method until 90 days after the last dose of study drug administration * male subject agrees to not donate sperm until 90 days after the dose of study drug administration * female subject is surgically sterile or is post-menopausal and is not pregnant and is not lactating * subject's 12-lead electrocardiogram (ecg) is normal * subject must be capable of swallowing multiple tablets exclusion criteria: * subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition * subject has had major gi surgery (such as colectomy, cholecystectomy, etc) * subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years * subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week * subject has a positive test for hepatitis c antibody, or positive test for hepatitis b surface antigen (hbsag), or positive hepatitis b core antibody * subject has a history of the human immunodeficiency virus (hiv) antibody * subject has a positive tuberculosis (tb) skin test, quantiferon gold test or t-spot® test * subject received any vaccine within 60 days * subject received an experimental agent within 30 days * subject has an absolute neutrophil count (anc) \< 2500 cells/mm3 * subject has had any significant blood loss, donated one unit (450 ml) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days * subject has a history of smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months

Keywords: asp015k healthy subjects bioavailability rheumatoid arthritis psoriasis transplantation